Repros soars again on Proellex drug study. Cephalon receives CRL. King Pharma and Pain Therapeutics resubmit NDA Print E-mail
By Mary Davila   
Monday, 27 December 2010 19:18
Below is a look at some of the headlines for companies that made news in the healthcare sector on December 27, 2010.

Shares of Repros Therapeutics Inc. (NasdaqCM:RPRX) climbed for a second straight trading session after the company Monday reported positive results for another of its experimental drugs, Proellex, which is being tested to treat uterine fibroids and endometriosis.

The company said it completed two animal model studies of the use of Proellex in a vaginally administered formulation that demonstrated effects on progesterone sensitive tissues equivalent to the highest oral dose formerly developed by Repros. The Company believes the high concentrations of the active ingredient and its primary metabolite attained in first pass absorption and processing by the liver resulted in the delayed toxicity exhibited in roughly 3-4% of the women administered the 50 mg dose of the drug in Phase III studies.

Shares of Repros shot up 94 cents or nearly 37% to $3.51.

Cephalon, Inc. (Nasdaq:CEPH) today announced that the company received a second Complete Response Letter from the U.S. Food and Drug Administration for the supplemental new drug application (sNDA) for NUVIGIL Tablets for the treatment of patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel. In its letter to the company, the FDA reiterated its previously stated concerns regarding the NUVIGIL sNDA.

"Cephalon believes we met the agreed upon safety and efficacy endpoints in the NUVIGIL sNDA clinical study conducted under a Special Protocol Assessment. However, following several conversations with the agency, and given this second complete response letter, the company believes that further communications with the FDA will not result in an approval of this application," said Dr. Lesley Russell, Chief Medical Officer at Cephalon. "As a result, the company is no longer pursuing this indication."


King Pharmaceuticals, Inc. (NYSE:KG) and Pain Therapeutics, Inc. (Nasdaq:PTIE) today announced that King has resubmitted a New Drug Application (NDA) for REMOXY (oxycodone) to the U.S. Food and Drug Administration (FDA) in response to a Complete Response letter received by Pain Therapeutics in December 2008. This is a Class 2 resubmission with a six month review cycle.

REMOXY is a twice daily, long-acting formulation of oral oxycodone for moderate to severe pain requiring continuous, around-the-clock opioid treatment for an extended period of time. REMOXY was developed by Pain Therapeutics, using DURECT Corporation's (Nasdaq:DRRX) ORADUR technology, to help address the growing problem of non-medical use of prescription opioids. REMOXY is comprised of a high-viscosity, liquid formulation in a hard gelatin capsule that is designed to provide steady, around-the-clock pain relief, while resisting common methods of tampering intended to result in the rapid release of oxycodone.

Hiru Corporation (PINK SHEETS:HIRU) management intends to adhere to its plan to grow on the Chinese vaccine and husbandry market and establish new contacts within the industry.

During the past few sessions, shares of Radient Pharmaceuticals (NYSE Amex: RPC) have seen increased volume and appreciation in anticipation of several key developments slated to occur in the short term.

Sun Healthcare Group, Inc. (NASDAQ: SUNH) today announced that William A. Mathies, the company's chairman and chief executive officer, and L. Bryan Shaul, the company's chief financial officer, will present at the 29th Annual J.P. Morgan Healthcare Conference on Monday, Jan. 10, 2011, at 3:30 p.m. Pacific.

 

 




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